September 2004 CO-ContractManuf.X-BasedHH.wpd
INSTRUCTIONS FOR PROGRAM MANAGERS
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF POLLUTION PREVENTION AND TOXICS
REGULATION OF A NEW CHEMICAL SUBSTANCE
PENDING DEVELOPMENT OF INFORMATION
In the matter of: ) Premanufacture Notice Number:
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_________________________________________________________________
Consent Order for Contract Manufacturer __________________________________
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CONSENT ORDER
I. SCOPE OF APPLICABILITY AND EXEMPTIONS
(a) Scope. ____________________ ("the Contract Manufacturer) has entered into a contract
with __________________ ("the Company") to manufacture or import exclusively for the
Company the chemical substance:_________________________________________(P-__-
____)("the PMN substance"). The requirements of this Order apply to all commercial
manufacturing, processing, distribution in commerce, use and disposal of the PMN substance in
the United States by the Contract Manufacturer, except to the extent that those activities are
exempted by paragraph (b).
(b) Exemptions. Manufacturing, processing, distribution in commerce, use and disposal of the
PMN substance is exempt from the requirements of this Order (except the requirements in the
Recordkeeping and Successor Liability Upon Transfer Of Consent Order sections) only to the
extent that (1) these activities are conducted in full compliance with all applicable requirements
of the following exemptions, and (2) such compliance is documented by appropriate
recordkeeping as required in the Recordkeeping section of this Order.
(1) Export. Until the Contract Manufacturer begins commercial manufacture of the
PMN substance for use in the United States, the requirements of this Order do not apply to
manufacture, processing or distribution in commerce of the PMN substance solely for export in
accordance with TSCA §12(a) and (b), 40 CFR 720.3(s) and 40 CFR Part 707. However, once
the Contract Manufacturer begins to manufacture the PMN substance for use in the United
States, no further activity by the Contract Manufacturer involving the PMN substance is exempt
as "solely for export" even if some amount of the PMN substance is later exported. At that point,
the requirements of this Order apply to all activities associated with the PMN substance while in
the territory of the United States. Prior to leaving U.S. territory, even those quantities or batches
of the PMN substance that are destined for export are subject to terms of the Order, and count
towards any production volume test triggers in the Testing section of this Order.
(2) Research & Development (R&D). The requirements of this Order do not apply to
manufacturing, processing, distribution in commerce, use and disposal of the PMN substance in
small quantities solely for research and development in accordance with TSCA §5(h)(3), 40 CFR
720.3(cc), and 40 CFR 720.36.
(3) Byproducts. The requirements of this Order do not apply to the PMN substance
when it is produced, without separate commercial intent, only as a "byproduct" as defined at 40
CFR 720.3(d) and in compliance with 40 CFR 720.30(g).
(4) No Separate Commercial Purpose. The requirements of this Order do not apply to
the PMN substance when it is manufactured, pursuant to any of the exemptions in 40 CFR
720.30(h), with no commercial purpose separate from the substance, mixture, or article of which
it is a part.
(c) Automatic Sunset. If the Contract Manufacturer has obtained for the PMN substance a Test
Market Exemption (TME) under TSCA §5(h)(1) and 40 CFR 720.38 or a Low Volume
Exemption (LVE) or Low Release and Exposure Exemption (LoREX) under TSCA §5(h)(4) and
40 CFR 723.50(c)(1) and (2) respectively, any such exemption is automatically rendered null and
void as of the effective date of this Consent Order.
II. TERMS OF MANUFACTURE, IMPORT, PROCESSING,
DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL
PENDING SUBMISSION AND EVALUATION OF INFORMATION
PROHIBITION
As a condition of manufacturing or importing the PMN substance for the Company, the
Contract Manufacturer is prohibited from manufacturing, importing, processing, distributing in
commerce, using, or disposing of the PMN substance for any non-exempt commercial purpose,
pending the development of information necessary for a reasoned evaluation of the health effects
[Note to Program Managers: Edit as appropriate.] of the substance, and the completion of
EPA's review of, and regulatory action based on that information, except in accordance with the
conditions described in this Order.
TESTING
Triggered Testing Requirements. The Contract Manufacturer is prohibited from
manufacturing or importing the PMN substance beyond the following aggregate manufacture and
import volumes ("the production limits"), unless the Company conducts the following studies on
the PMN substance and submits all final reports and underlying data in accordance with the
conditions specified in the Testing section of the Consent Order for the Company.
Production Limit Study Guideline
Acute Oral Toxicity Study OPPTS 870.1100 or OECD
425 "Acute Oral Toxicity:
Up-Down Procedure"
Bacterial Reverse Mutation Test OPPTS 870.5100
Mammalian Erythrocyte OPPTS 870.5395
Micronucleus Test (Intraperitoneal
route)
Repeated Dose 28-day Oral OPPTS 870.3050 or
Toxicity In Rodents - OECD 407
This study should include, for all
test doses, a neurotoxicity functional
observational battery, as described in
OPPTS 870.6200 ("Neurotoxicity
screening battery")
Prenatal Developmental Toxicity OPPTS 870.3700
Study (one species, oral route)
MANUFACTURING
(a)(1) Prohibition. The Contract Manufacturer shall not begin manufacture or import of the
PMN substance until the Contract Manufacturer or the Company receives a fully executed copy
of the Consent Order for Contract Manufacture from EPA.
(2) The Contract Manufacturer shall not cause, encourage, or suggest the manufacture or
import of the PMN substance by any other person.
(3) Sunset Following SNUR. Subparagraph (a)(1) shall expire 75 days after
promulgation of a final significant new use rule ("SNUR") governing the PMN substance under
section 5(a)(2) of TSCA unless the Contract Manufacturer is notified on or before that day of an
action in a Federal Court seeking judicial review of the SNUR. If the Contract Manufacturer is
so notified, subparagraph (a)(1) shall not expire until EPA notifies the Contract Manufacturer in
writing that all Federal Court actions involving the SNUR have been resolved and the validity of
the SNUR affirmed.
(4) Notice of SNUR. When EPA promulgates a final SNUR for the PMN substance and
subparagraph (a)(1) expires in accordance with subparagraph (a)(2), the Contract Manufacturer
shall notify each person whom it causes, encourages or suggests to manufacture or import the
PMN substance of the existence of the SNUR.
RISK NOTIFICATION
(a) If as a result of the test data required under the terms of this Order, the Company or Contract
Manufacturer becomes aware that the PMN substance may present a risk of injury to human
health (or is so notified by EPA), the Contract Manufacuturer must incorporate this new
information, and any information on methods for protecting against such risk, into a Material
Safety Data Sheet ("MSDS"), as described in 40 CFR section 721.72(c), within 90 days from the
time the Company or Contract Manufacturer becomes aware of the new information. If the PMN
substance is not being manufactured, imported, processed, or used in the Contract Manufacturer's
workplace, the Contract Manufacuter must add the new information to an MSDS before the
PMN substance is reintroduced into the workplace.
(b) The Contract Manufacturer must ensure that persons who will receive the PMN substance
from the Contract Manufacturer, or who have received the PMN substance from the Contract
Manufacturer within 5 years from the date the Company or Contract Manufacturer becomes
aware of the new information described in paragraph (a) of this section, are provided an MSDS
containing the information required under paragraph (a) within 90 days from the time the
Company or Contract Manufacturer becomes aware of the new information.
III. RECORDKEEPING
(a) Records. The Contract Manufacturer shall maintain the following records until 5 years after
the date they are created and shall make them available for inspection and copying by EPA in
accordance with section 11 of TSCA:
(1) Exemptions. Records documenting that the PMN substance did in fact qualify for any
one or more of the exemptions described in Section I, Paragraph (b) of this Order. Such records
must satisfy all the statutory and regulatory recordkeeping requirements applicable to the
exemption being claimed by the Contract Manufacturer. Any amounts or batches of the PMN
substance eligible for the Export exemption in Section I, Paragraph (b)(3) of this Order, are
exempt from all the requirements in this Recordkeeping section, if the Contract Manufacturer
maintains, for 5 years from the date of their creation, copies of the export label and export notice
to EPA, required by TSCA sections 12(a)(1)(B) and 12(b), respectively. Any amounts or batches
of the PMN substance eligible for the Research and Development exemption in Section I,
Paragraph (b)(4) of this Order, are exempt from all the requirements in this Recordkeeping
section, if the Contract Manufacturer maintains, for 5 years from the date of their creation, the
records required by 40 CFR 720.78(b). For any amounts or batches of the PMN substance
claimed to be eligible for any other exemption described in Section I, Paragraph (b) of this Order,
the Contract Manufacturer shall keep records demonstrating qualification for that exemption as
well as the records specified in paragraphs (2) and (3) below, but is exempt from the other
recordkeeping requirements in this Recordkeeping section;
(2) Records documenting the manufacture and importation volume of the PMN
substance and the corresponding dates of manufacture and import;
(3) Records documenting the names and addresses (including shipment destination
address, if different) of all persons outside the site of manufacture or import to whom the
Contract Manufacturer directly sells or transfers the PMN substance, the date of each sale or
transfer, and the quantity of the substance sold or transferred on such date;
(4) Records documenting the address, of all sites of manufacture, import, processing, and
use;
(5) Copies of material safety data sheets required by the Risk Notificaion section of this
Order;
(6) The Contract Manufacturer shall keep a copy of this Order at each of its sites where
the PMN substance is manufactured of imported.
(b) Applicability. The provisions of this Recordkeeping Section are applicable only to activities
of the Contract Manufacturer and its Contract Manufacturer, if applicable, and not to activities of
the Contract Manufacturer's customers.
(c) OMB Control Number. Under the Paperwork Reduction Act and its regulations at 5 CFR
Part 1320, particularly 5 CFR 1320.5(b), the Contract Manufacturer is not required to respond to
this "collection of information" unless this Order displays a currently valid control number from
the Office of Management and Budget (OMB), and EPA so informs the Contract Manufacturer.
The "collection of information" required in this TSCA §5(e) Consent Orders has been approved
under currently valid OMB Control Number 2070-0012.
IV. REQUESTS FOR PRE-INSPECTION INFORMATION
(a) EPA's Request for Information. Pursuant to section 11 of TSCA and 40 CFR 720.122, EPA
may ocassionally conduct on-site compliance inspections of Contract Manufacturer facilities and
conveyances associated with the PMN substance. To facilitate such inspections, EPA personnel
may contact the Contract Manufacturer in advance to request information pertinent to the
scheduling and conduct of such inspections. Such requests may be written or oral. The types of
information that EPA may request may include, but are not limited to, the following:
(i) Expected dates and times when the PMN substance will be in production within the
subsequent 12 months;
(ii) Current workshift schedules for workers who are involved in activities associated
with the PMN substance and may reasonably be exposed to the PMN substance;
(iii) Current job titles or categories for workers who are involved in activities associated
with the PMN substance and may reasonably be exposed to the PMN substance;
(iv) Existing exposure monitoring data for workers who are involved in activities
associated with the PMN substance and may reasonably be exposed to the PMN substance;
(v) Records required by the Recordkeeping section of this Order; and/or
(vi) Any other information reasonably related to determining compliance with this Order
or conducting an inspection for that purpose.
(b) Contract Manufacturer's Response. The Contract Manufacturer shall respond to such
requests within a reasonable period of time, but in no event later than 30 days after receiving
EPA's request. When requested in writing by EPA, the Contract Manufacturer's response shall
be in writing. To the extent the information is known to or reasonably ascertainable to the
Contract Manufacturer at the time of the request, the Contract Manufacturer's response shall
demonstrate a good faith effort to provide reasonably accurate and detailed answers to all of
EPA's requests.
(c) Confidential Business Information. Any Confidential Business Information (CBI) that the
Contract Manufacturer submits to EPA pursuant to paragraph (b) shall be protected in
accordance with §14 of TSCA and 40 CFR Part 2.
V. MODIFICATION AND REVOCATION OF CONSENT ORDER
The Contract Manufacturer may petition EPA at any time, based upon new information
on the human health effects of, or human exposures to, the PMN substance, to modify or revoke
substantive provisions of this Order. The exposures and risks identified by EPA during its
review of the PMN substance and the information EPA determined to be necessary to evaluate
those exposures and risks are described in the preamble to this Order. However, in determining
whether to amend or revoke this Order, EPA will consider all relevant information available at
the time the Agency makes that determination, including, where appropriate, any reassessment of
the test data or other information that supports the findings in this Order, an examination of new
test data or other information or analysis, and any other relevant information.
EPA will issue a modification or revocation if EPA determines that the activities
proposed therein will not present an unreasonable risk of injury to health or the environment and
will not result in significant or substantial human exposure or substantial environmental release
in the absence of data sufficient to permit a reasoned evaluation of the health or environmental
effects of the PMN substance.
In addition, the Contract Manufacturer may petition EPA at any time to make other
modifications to the language of this Order. EPA will issue such a modification if EPA
determines that the
modification is useful, appropriate, and consistent with the structure and intent of this Order as
issued. VI. EFFECT OF CONSENT ORDER
By consenting to the entry of this Order, the Contract Manufacturer waives its rights to
file objections to this Order pursuant to section 5(e)(1)(C) of TSCA, to receive service of this
Order no later than 45 days before the end of the review period pursuant to section 5(e)(1)(B) of
TSCA, and to challenge the validity of this Order in any subsequent action. Consenting to the
entry of this Order, and agreeing to be bound by its terms, do not constitute an admission by the
Contract Manufacturer as to, the facts or conclusions underlying the Agency's determinations in
this proceeding. This waiver does not affect any other rights that the Contract Manufacturer may
have under TSCA.
Date Wardner G. Penberthey, Acting Director
Chemical Control Division
Office of Pollution Prevention and Toxics
Date Name:
Title:
Contract Manufacturer:
ATTACHMENT A
DEFINITIONS
[Note: The attached Order may not contain some of the terms defined below.]
"Chemical name" means the scientific designation of a chemical substance in accordance
with the nomenclature system developed by the International Union of Pure and Applied
Chemistry or the Chemical Abstracts Service's rules of nomenclature, or a name which will
clearly identify a chemical substance for the purpose of conducting a hazard evaluation.
"Chemical protective clothing" means items of clothing that provide a protective barrier
to prevent dermal contact with chemical substances of concern. Examples can include, but are
not limited to: full body protective clothing, boots, coveralls, gloves, jackets, and pants.
"Company" means the person who submitted the pre-manufacture notice (PMN) and who
is subject to the Consent Order to which this Consent Order for Contract Manufacturer is an
attachment.
"Commercial use" means the use of a chemical substance or any mixture containing the
chemical substance in a commercial enterprise providing saleable goods or a service to
consumers (e.g., a commercial dry cleaning establishment or painting contractor).
"Common name" means any designation or identification such as code name, code
number, trade name, brand name, or generic chemical name used to identify a chemical substance
other than by its chemical name.
"Consumer" means a private individual who uses a chemical substance or any product
containing the chemical substance in or around a permanent or temporary household or
residence, during recreation, or for any personal use or enjoyment.
"Consumer product" means a chemical substance that is directly, or as part of a mixture,
sold or made available to consumers for their use in or around a permanent or temporary
household or residence, in or around a school, or in recreation.
"Container" means any bag, barrel, bottle, box, can, cylinder, drum, reaction vessel,
storage tank, or the like that contains a hazardous chemical. For purposes of this section, pipes
or piping systems, and engines, fuel tanks, or other operating systems in a vehicle, are not
considered to be containers.
"Contract Manufacturer" means a person, outside the Company, who is authorized to
manufacture and import the PMN substance under the conditions specified in this Consent Order
for Contract Manufacturer and in Part II. of the Company's Consent Order.
"Identity" means any chemical or common name used to identify a chemical substance or
a mixture containing that substance.
"Immediate use." A chemical substance is for the "immediate use" of a person if it is
under the control of, and used only by, the person who transferred it from a labeled container and
will only be used by that person within the work shift in which it is transferred from the labelled
container.
"Impervious." Chemical protective clothing is "impervious" to a chemical substance if
the substance causes no chemical or mechanical degradation, permeation, or penetration of the
chemical protective clothing under the conditions of, and the duration of, exposure.
"Manufacturing stream" means all reasonably anticipated transfer, flow, or disposal of a
chemical substance, regardless of physical state or concentration, through all intended operations
of manufacture, including the cleaning of equipment.
"MSDS" means material safety data sheet, the written listing of data for the chemical
substance.
"NIOSH" means the National Institute for Occupational Safety and Health of the U.S.
Department of Health and Human Services.
"Non-enclosed process" means any equipment system (such as an open-top reactor,
storage tank, or mixing vessel) in which a chemical substance is manufactured, processed, or
otherwise used where significant direct contact of the bulk chemical substance and the workplace
air may occur.
"Non-industrial use" means use other than at a facility where chemical substances or
mixtures are manufactured, imported, or processed.
"PMN substance" means the chemical substance described in the Premanufacture notice
submitted by the Company relevant to this Order.
"Personal protective equipment" means any chemical protective clothing or device placed
on the body to prevent contact with, and exposure to, an identified chemical substance or
substances in the work area. Examples include, but are not limited to, chemical protective
clothing, aprons, hoods, chemical goggles, face splash shields, or equivalent eye protection, and
various types of respirators. Barrier creams are not included in this definition.
"Process stream" means all reasonably anticipated transfer, flow, or disposal of a
chemical substance, regardless of physical state or concentration, through all intended operations
of processing, including the cleaning of equipment.
"Scientifically invalid" means any significant departure from the EPA-approved protocol
or the Good Laboratory Practice Standards at 40 CFR Part 792 without prior or subsequent
Agency approval that prevents a reasoned evaluation of the health or environmental effects of the
PMN substance.
"Scientifically equivocal data" means data which, although developed in apparent
conformity with the Good Laboratory Practice Standards and EPA-approved protocols, are
inconclusive, internally inconsistent, or otherwise insufficient to permit a reasoned evaluation of
the potential risk of injury to human health or the environment of the PMN substance.
"Sealed container" means a closed container that is physically and chemically suitable for
long-term containment of the PMN substance, and from which there will be no human exposure
to, nor environmental release of, the PMN substance during transport and storage.
"Use stream" means all reasonably anticipated transfer, flow, or disposal of a chemical
substance, regardless of physical state or concentration, through all intended operations of
industrial, commercial, or consumer use.
"Waters of the United States" has the meaning set forth in 40 CFR 122.2.
"Work area" means a room or defined space in a workplace where the PMN substance is
manufactured, processed, or used and where employees are present.
"Workplace" means an establishment at one geographic location containing one or more
work areas.